EU approval for Bioenvision's Evoltra

New York, USA-based Bioenvision says that the European Commission has granted marketing authorization for Evoltra (clofarabine) for the treatment of acute lymphoblastic leukemia in pediatric patients who have relapsed or are refractory to at least two prior regimens, and where there is no other treatment option anticipated to result in a durable response. The licensed indication includes patients who were less than 21 years old at the time of initial diagnosis of their leukemia.

"This is a momentous day for children suffering from ALL and the doctors who treat them," said Hugh Griffith, Bioenvision's chief operating officer. "By approving Evoltra in Europe the European Commission is giving patients and their families a new treatment option and new hope," he added.

Although the first-line treatment of children with leukemia is generally successful, patients with multiple relapsed or refractory leukemia have a low response rate and a very poor prognosis, with a median survival of around 8-10 weeks. In the pivotal clinical study with Evoltra a median survival of 66.6 weeks was achieved in the 30% of children who responded to treatment. In addition to extending the life of children who responded to therapy, Evoltra also gives them the opportunity to receive a bone marrow transplant, which offers the chance of a potential cure.